United States Patent 10,278,923: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,278,923, assigned to Novo Nordisk A/S, is a critical patent that protects the pharmaceutical product RYBELSUS, which contains the active ingredient semaglutide. This patent is part of a broader portfolio of patents that safeguard Novo Nordisk's intellectual property in the field of GLP-1 agonists. Here, we delve into the scope, claims, and the surrounding patent landscape of this significant patent.
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent No. 10,278,923, titled "Solid Compositions Comprising a GLP-1 Agonist and a Salt of N-(8-(2-Hydroxybenzoyl)Amino)Caprylic Acid"[2][4].
Inventors and Assignees
The patent lists several inventors, including Per Sauerberg, Simon Bjerredgaard, and Flemming Seier Nielsen, among others. All rights, title, and interest in the patent are assigned to Novo Nordisk A/S[2][4].
Claims
Primary Claims
The patent claims cover solid compositions for oral administration that include a GLP-1 agonist, specifically semaglutide, and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. These compositions also include at least one excipient such as a lubricant, binder, or filler[2][4].
Specific Claim Details
- The patent claims a compound with a specific structure, which is semaglutide, and pharmaceutical compositions comprising this compound along with pharmaceutically acceptable excipients.
- It also covers the method of preparing these solid compositions and their use in treating various conditions, such as type 2 diabetes and obesity[2][5].
Patent Scope
Metrics for Measuring Patent Scope
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. For U.S. Patent 10,278,923, the claims are specific and detailed, indicating a well-defined scope[3].
International Protection
This patent is part of a larger family of patents with international protection. It has thirty-four patent family members in twenty-three countries, including Australia, Brazil, Canada, and several European countries. This extensive international coverage ensures broad protection for Novo Nordisk's intellectual property[1].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 10,278,923 includes several related patents that collectively protect various aspects of semaglutide and its formulations. These include:
- U.S. Patent No. 8,129,343: Covers acylated GLP-1 compounds.
- U.S. Patent No. 8,536,122: Also covers acylated GLP-1 compounds.
- U.S. Patent No. 9,278,123: Covers specific pharmaceutical compositions.
- U.S. Patent No. 10,086,047: Covers methods of treatment using GLP-1 agonists.
- U.S. Patent No. 10,933,120 and others: These patents collectively protect the formulation, use, and preparation methods of semaglutide[2][5].
Litigation and Generic Challenges
The patent has been subject to litigation, particularly with regards to generic challenges. Apotex has filed an Abbreviated New Drug Application (ANDA) seeking approval for a generic version of RYBELSUS before the expiration of the asserted patents. Novo Nordisk has responded with a lawsuit alleging infringement of the patent claims[2][5].
Expiration and Generic Entry
Estimated Expiration Dates
The estimated expiration dates for U.S. Patent 10,278,923 and its related patents vary, but they generally fall within the mid to late 2020s and early 2030s. The exact expiration dates depend on the specific patent and any supplementary protection certificates (SPCs) that may be in place[1].
Impact on Generic Entry
The expiration of these patents will pave the way for generic versions of semaglutide to enter the market. However, until then, Novo Nordisk retains exclusive rights to manufacture, use, and sell RYBELSUS, protecting its market position[1][2].
Strategic Importance
Market Protection
The patent provides significant market protection for Novo Nordisk, allowing the company to maintain its competitive edge in the GLP-1 agonist market. This protection is crucial for the company's revenue and market share[2].
Innovation Incentives
The patent also serves as an incentive for continued innovation. By protecting intellectual property, companies like Novo Nordisk are encouraged to invest in research and development, leading to further advancements in pharmaceuticals[3].
Conclusion
U.S. Patent 10,278,923 is a pivotal patent in the pharmaceutical industry, particularly in the field of GLP-1 agonists. Its specific claims, international protection, and strategic importance make it a cornerstone of Novo Nordisk's intellectual property portfolio. As the patent landscape evolves with litigation and the approach of expiration dates, it will be interesting to see how the market for semaglutide and related products changes.
Key Takeaways
- Specific Claims: The patent covers solid compositions for oral administration of semaglutide with specific excipients.
- International Protection: Extensive protection in twenty-three countries.
- Related Patents: Part of a larger portfolio protecting various aspects of semaglutide.
- Litigation: Subject to litigation over generic challenges.
- Expiration Dates: Estimated to expire in the mid to late 2020s and early 2030s.
- Strategic Importance: Crucial for market protection and innovation incentives.
FAQs
What is the main subject of U.S. Patent 10,278,923?
The main subject of U.S. Patent 10,278,923 is the solid compositions for oral administration of the GLP-1 agonist semaglutide, along with a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
Who is the assignee of U.S. Patent 10,278,923?
The assignee of U.S. Patent 10,278,923 is Novo Nordisk A/S.
What is the international scope of U.S. Patent 10,278,923?
The patent has thirty-four patent family members in twenty-three countries, providing extensive international protection.
What are the related patents to U.S. Patent 10,278,923?
Related patents include U.S. Patent Nos. 8,129,343, 8,536,122, 9,278,123, 10,086,047, and others that collectively protect various aspects of semaglutide and its formulations.
Why is U.S. Patent 10,278,923 important for Novo Nordisk?
The patent is crucial for Novo Nordisk as it provides market protection and incentives for continued innovation in the field of GLP-1 agonists.
When is U.S. Patent 10,278,923 expected to expire?
The exact expiration date is not specified, but it is estimated to be in the mid to late 2020s and early 2030s, depending on supplementary protection certificates.
Sources
- DrugPatentWatch: Pharmaceutical drugs covered by patent 10,278,923.
- RPX Insight: Case 1:24-cv-09729-RMB-AMD Document 17.
- SSRN: Patent Claims and Patent Scope.
- Google Patents: United States Patent 10,278,923.
- RPX Insight: Case 1:24-cv-09729-RMB Document 1.
